The Trump ad­min­is­tra­tion has en­dured a set­back af­ter a fed­er­al court over­turned a rul­ing — oblig­at­ing drug man­u­fac­tur­ers to dis­close the list price of their ther­a­pies in tele­vi­sion ad­verts — hours be­fore it was stip­u­lat­ed to go in­to ef­fect.

In May, the HHS pub­lished a fi­nal rul­ing re­quir­ing drug­mak­ers to di­vulge the whole­sale ac­qui­si­tion cost— of a 30-day sup­ply of the drug — in tv ads in a bid to en­hance price trans­paren­cy in the Unit­ed States. The phar­ma­ceu­ti­cal in­dus­try has ve­he­ment­ly op­posed the rule, as­sert­ing that list prices are not what a typ­i­cal pa­tient in the Unit­ed States pays for treat­ment — that num­ber is typ­i­cal­ly de­ter­mined by the type of (or lack there­of) in­sur­ance cov­er­age, de­ductibles and out-of-pock­et costs. Al­though there is truth to that claim, the move was con­sid­ered sym­bol­ic in the Trump ad­min­is­tra­tion’s health­care agen­da to hold drug­mak­ers ac­count­able in a cli­mate where sky­rock­et­ing drug prices have in­censed Amer­i­cans on both sides of the aisle.

The suit, va­cat­ed by a DC fed­er­al judge on Mon­day, was brought on by a tri­fec­ta of drug­mak­ers: Mer­ck $MRK, Eli Lil­ly $LLY and Am­gen $AMGN, in ad­di­tion to the Na­tion­al As­so­ci­a­tion of Ad­ver­tis­ers, a trade as­so­ci­a­tion. They ar­gued that the rule eclipsed HHS’s au­thor­i­ty be­cause Con­gress “nei­ther ex­press­ly nor im­plied­ly grant­ed HHS the pow­er un­der the So­cial Se­cu­ri­ty Act to reg­u­late drug mar­ket­ing” and con­tend­ed that com­pelled speech vi­o­lat­ed the First Amend­ment.

The court agreed that the HHS does not have the statu­to­ry au­thor­i­ty to im­ple­ment the drug price dis­clo­sure rul­ing. Al­though the court does not take “any view on the wis­dom of re­quir­ing drug com­pa­nies to dis­close prices. That pol­i­cy very well could be an ef­fec­tive tool in halt­ing the ris­ing cost of pre­scrip­tion drugs. But no mat­ter how vex­ing the prob­lem of spi­ral­ing drug costs may be, HHS can­not do more than what Con­gress has au­tho­rized,” it con­clud­ed.

The Amer­i­can As­so­ci­a­tion of Re­tired Per­sons (AARP), a non-prof­it or­ga­ni­za­tion that ad­vo­cates for the el­der­ly, said it was dis­ap­point­ed by the court’s de­ci­sion.

Nan­cy Lea­Mond AARP

“High drug prices dis­pro­por­tion­ate­ly hurt old­er Amer­i­cans, par­tic­u­lar­ly Medicare Part D en­rollees who take an av­er­age of 4.5 pre­scrip­tion med­ica­tions each month. Most Medicare ben­e­fi­cia­ries live on fixed in­comes, with a me­di­an an­nu­al in­come of just over $26,000,” AARP ex­ec­u­tive VP and chief ad­vo­ca­cy and en­gage­ment of­fi­cer Nan­cy Lea­Mond said in a state­ment. “To­day’s rul­ing is a step back­ward in the bat­tle against sky­rock­et­ing drug prices and pro­vid­ing more in­for­ma­tion to con­sumers. Amer­i­cans should be trust­ed to eval­u­ate drug price in­for­ma­tion and dis­cuss any con­cerns with their health care providers.”

Trump has long lam­bast­ed the phar­ma­ceu­ti­cal in­dus­try for its pric­ing poli­cies. Af­ter cap­tur­ing the pres­i­den­cy, Trump pro­claimed drug­mak­ers were “get­ting away with mur­der.” His ad­min­is­tra­tion has since un­veiled a string of pro­pos­als to tem­per pric­ing, in­clud­ing one last year en­gi­neered to peg drug prices to over­seas rates for Medicare ben­e­fi­cia­ries.

As he mounts his re-elec­tion bid for 2020, Trump sug­gest­ed on Fri­day that an ex­ec­u­tive or­der is be­ing pre­pared to im­ple­ment a “fa­vored na­tions clause” to re­duce drug prices in the Unit­ed States, in con­ver­sa­tion with re­porters on the south lawn of the White House.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”